Blood Set 1273002

GUDID 20887787008832

Primary Y-Type Blood Set 200 Micron Filter, Bulb Pump, Prepierced Y-Site, Secure Lock, 80 Inch (previously Hospira product)

ICU MEDICAL FLEET SERVICES, LLC

Blood transfusion set

• Primary Device ID: 20887787008832
• NIH Device Record Key: 1d4505c3-3cf2-4a9f-9ffe-325c939ccdce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Set
• Version Model Number: 1273002
• Catalog Number: 1273002
• Company DUNS: 830767898
• Company Name: ICU MEDICAL FLEET SERVICES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887787009146 [Primary]
GS1	20887787008832 [Package]; Contains: 10887787009146; Package: Corrugated Box [48 Units]; In Commercial Distribution
HIBCC	M33512730020 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143087

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-04

Devices Manufactured by ICU MEDICAL FLEET SERVICES, LLC

• 00840619085421 - ICU Medical: 2021-09-03 Optical Module, Black, OPMOD
• 10887787009115 - ICU Medical MedNet: 2020-01-22 Mednet Software
• 20887787003233 - Plum: 2019-12-11 Primary PLUM Set 0.2 Micron Filter, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 112 Inch (previously Hospira product)
• 20887787003431 - Plum: 2019-12-11 Primary PLUM MICRODRIP Set CLAVE Secondary Port, Backcheck Valve, CLAVE Y-Site, Secure Lock, 104 Inch (previously Hospira produc
• 20887787005015 - Lifeshield: 2019-12-11 Microbore Extension Set, 10 Inch 0.2 Micron Filter, Prepierced Y-Site, Secure Lock (previously Hospira product)
• 20887787006715 - TUR System: 2019-12-11 LATEX-FREE T-U-R SYSTEM WITH FLOW-POUCH RESERVOIR-2000 mL For Transurethral Resection Procedures For Use With Flexible Container
• 20887787006722 - TUR Set: 2019-12-11 LATEX-FREE T-U-R Y-Set Nonvented Set for Transurethral Resection Procedures 96 inch (244 cm) For Flexible Irrigation Container S
• 20887787007248 - Irrigation Set: 2019-12-11 LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection Procedures 85 inch (216 cm) (previously Hospira